Velmanase alfa-tycv

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Velmanase alfa-tycv
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rithish Nimmagadda,MBBS.[2]

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Overview

Velmanase alfa-tycv is an recombinant preparation of human lysosomal alpha-mannosidase that is FDA approved for the treatment of non-central nervous system manifestations of alpha-mannosidosis in adult and pediatric patients. Common adverse reactions include Most common adverse reactions (incidence >20%) are hypersensitivity reactions (including anaphylaxis), nasopharyngitis, pyrexia, headache, and arthralgia..

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Recommended velmanase alfa-tycv dosage is 1 mg/kg (actual body weight) administered once every week as an IV infusion.

The total volume of infusion is determined by the patient’s actual body weight and should be administered over a minimum of 60 minutes for patients weighing up to 49 kg. Patients weighing 50 kg and greater should be infused at a maximum infusion rate of 25 mL/hour to control the protein load.

See the full prescribing information for reconstitution and administration instructions, and also for dosage modification guidelines for hypersensitivity reactions and/or infusion-associated reactions

Off-Label Use and Dosage (Adult)

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Recommended velmanase alfa-tycv dosage is 1 mg/kg (actual body weight) administered once every week as an IV infusion.

Off-Label Use and Dosage (Pediatric)

Contraindications

None

Warnings

-Hypersensitivity Reactions Including Anaphylaxis

Hypersensitivity reactions including anaphylaxis have been reported in velmanase alfa-treated patients. In clinical trials, 19 (50%) velmanase alfa-tycv-treated patients (5 adult patients and 14 pediatric patients) experienced hypersensitivity reactions, including 2 (5%) patients (1 adult patient and 1 pediatric patient) who experienced anaphylaxis and an additional 3 (8%) pediatric patients who experienced severe hypersensitivity reactions that required medical treatment.

In the 5 patients who experienced anaphylaxis or severe hypersensitivity requiring medical treatment, 4 (80%) were anti-drug antibody (ADA) positive.

Anaphylaxis and severe hypersensitivity signs and symptoms included cyanosis, hypotension, emesis, urticaria, erythema, facial swelling, pyrexia, and tremor.

Prior to velmanase alfa-tycv administration, consider pretreating with antihistamines, antipyretics, and/or corticosteroids. Appropriate medical support measures, including cardiopulmonary resuscitation equipment, should be readily available during velmanase alfa-tycv administration.

If a severe hypersensitivity reaction (e.g., anaphylaxis) occurs, discontinue velmanase alfa-tycv immediately and initiate appropriate medical treatment. Consider the risks and benefits of re-administering the drug following severe hypersensitivity reactions (including anaphylaxis).Patients may be rechallenged using slower infusion rates.In patients with severe hypersensitivity reaction, desensitization measures to velmanase alfa-tycv may be considered. If the decision is made to readminister velmanase alfa-tycv, ensure the patient tolerates the infusion.If the patient tolerates the infusion, the rate may be increased to reach the recommended dosage.

If a mild or moderate hypersensitivity reaction occurs, consider slowing the infusion rate or temporarily withholding the dose.

-Infusion-associated Reactions

Infusion-associated reactions (IARs) have been reported in velmanase alfa-treated patient. In clinical trials 19 (50%) velmanase alfa-tycv-treated patients (3 adult and 16 pediatric patients) experienced IARs. [ref] Of these 19 patients, 5 (13 % of all patients) required pretreatment in the clinical trials.One velmanase alfa-tycv-treated patient in clinical trials discontinued due to recurrent IARs.

The most frequent symptoms of IARs that occurred in >10% of the population were pyrexia, chills, erythema, vomiting, cough, urticaria, rash and conjunctivitis.Similar symptoms were observed in adult and pediatric populations.

Prior to velmanase alfa-tycv administration, consider pretreating with antihistamines, antipyretics, and/or corticosteroids to reduce the risk of IARs. However, IARs may still occur in patients after receiving pretreatment.

If a severe IAR occurs, discontinue velmanase alfa-tycv immediately and initiate appropriate medical treatment. Consider the risks and benefits of readministering velmanase alfa-tycv following a severe IAR. Patients may be rechallenged using slower infusion rates.Once a patient tolerates the infusion, the infusion rate may be increased to reach the recommended infusion rate.

If a mild or moderate IAR occurs, consider slowing the infusion rate or temporarily withholding the dose.

-Embryo-fetal Toxicity

Based on findings from animal reproduction studies, velmanase alfa-tycv may cause embryo-fetal harm when administered to a pregnant female. Administration of velmanase alfa-tycv to pregnant rats during the period of organogenesis caused skeletal and visceral malformations. [ref] In rats and rabbits, skeletal and visceral malformations were observed at exposures that were approximately 7- and 2.5-fold, respectively, those observed in patients treated at the recommended dose of 1 mg/kg.

The decision to continue or discontinue velmanase alfa-tycv treatment during pregnancy should consider the female’s need for velmanase alfa-tycv, the potential drug-related risks to the fetus, and the potential adverse outcomes from untreated maternal disease.

For females of reproductive potential, verify that the patient is not pregnant prior to initiating treatment with velmanase alfa-tycv. Advise females of reproductive potential to use effective contraception during treatment with velmanase alfa-tycv and for 14 days after the last dose if the drug is discontinued.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Velmanase alfa-tycv Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Velmanase alfa-tycv Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Velmanase alfa-tycv Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): Based on findings from animal reproduction studies, velmanase alfa-tycv may cause embryo-fetal harm when administered to a pregnant female.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Velmanase alfa-tycv in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Velmanase alfa-tycv during labor and delivery.

Nursing Mothers

There are no data on the presence of velmanase alfa-tycv or its metabolite in either human or animal milk, the effects on the breastfed infant, or the effects on milk production.

Pediatric Use

The safety and effectiveness of velmanase alfa-tycv for the treatment of alpha-mannosidosis have been established in pediatric patients.

Use of velmanase alfa-tycv for this indication is supported by evidence from an adequate and well-controlled clinical trial in adult and pediatric patients, and from an open label trial in 5 pediatric patients (younger than 6 years of age)

Geriatic Use

There is no FDA guidance on the use of Velmanase alfa-tycv in geriatric settings.

Gender

There is no FDA guidance on the use of Velmanase alfa-tycv with respect to specific gender populations.

Race

There is no FDA guidance on the use of Velmanase alfa-tycv with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Velmanase alfa-tycv in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Velmanase alfa-tycv in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Velmanase alfa-tycv in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Velmanase alfa-tycv in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Velmanase alfa-tycv Administration in the drug label.

Monitoring

-Risk of hypersensitivity reactions including anaphylaxis and infusion-association reactions (IARs). Advise the patient and caregiver that reactions related to the infusion may occur during and after velmanase alfa-tycv treatment, including anaphylactic reactions, other serious or severe hypersensitivity reactions, and IARs. [ref] Inform the patient and caregiver of the signs and symptoms of hypersensitivity reactions and IARs and to seek medical care should signs and symptoms occur.

Velmanase alfa-tycv may cause embryo-fetal harm. Advise pregnant females of the potential risk to the fetus. [ref] Advise such female patients or their caregivers to inform their healthcare provider of a known or suspected pregnancy.


Advise females of reproductive potential to use effective contraception during treatment and for 14 days after the last dose if velmanase alfa-tycv is discontinued.

IV Compatibility

There is limited information regarding the compatibility of Velmanase alfa-tycv and IV administrations.

Overdosage

There is limited information regarding Velmanase alfa-tycv overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Velmanase alfa-tycv Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Velmanase alfa-tycv Mechanism of Action in the drug label.

Structure

There is limited information regarding Velmanase alfa-tycv Structure in the drug label.

Pharmacodynamics

There is limited information regarding Velmanase alfa-tycv Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Velmanase alfa-tycv Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Velmanase alfa-tycv Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Velmanase alfa-tycv Clinical Studies in the drug label.

How Supplied

There is limited information regarding Velmanase alfa-tycv How Supplied in the drug label.

Storage

There is limited information regarding Velmanase alfa-tycv Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Velmanase alfa-tycv Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Velmanase alfa-tycv interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.

Brand Names

Lamzede®

Look-Alike Drug Names

There is limited information regarding Velmanase alfa-tycv Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.